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COVID-19/Flu A+B Ag Rapid Test

by GenSure Biotech Inc. EUDAMED

Active European Union

Ref P2007C05Model P2007C01, P2007C02, P2007C05, P2007C20

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697683823P200700EQ Basic UDI-DIDate3 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6211186CE01 Issued

    Quality management system EU IVDR

    Notified body
    Notified body 0344
    Issued
    20 Jan 2026
    Expires
    1 Jan 2031
  • 6211186TD01 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 0344
    Issued
    20 Jan 2026
    Expires
    1 Jan 2031

Specification

EUDAMED

Model / Reference
P2007C01, P2007C02, P2007C05, P2007C20
Primary DI / UDI-DI
16976838230555
Basic UDI-DI
697683823P200700EQ
EMDN Code
W0105090601 Coronavirus / influenza - rt & poc
Device Class
Class C
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000028354
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from GenSure Biotech Inc.

See all devices from GenSure Biotech Inc. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing
  • Professional Testing
  • New Device

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No